Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants
Check against the official notice below — it lists the full affected range.
Nobel Biocare USA LLC is recalling Guided Start Drills/Counterbore NobRpl NP devices used for preparing bone sites in dental implant surgery. The recall was issued because a problem with the packaging sealing process at the supplier means the sterilized devices cannot be guaranteed to remain sterile throughout their shelf-life.
The affected devices were distributed worldwide, including throughout the United States and countries including Canada, Australia, Japan, Brazil, and numerous European nations. The recall involves lot/code (01)07332747005295(10)73425 with catalog number 32737. The source does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Reason for recall: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. Distribution: Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE. Quantity: None Lot/code info: (01)07332747005295(10)73425 Catalog# 32737
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.